150 Participants Needed

4-Aminopyridine for Skin Wounds

AH
Overseen ByAndrea Horne
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a drug called 4-aminopyridine (4-AP) can accelerate wound healing. Researchers aim to determine if this treatment benefits individuals with both chronic (long-lasting) and acute (sudden) wounds. Participants will receive either the 4-AP treatment or a placebo (a pill with no active ingredient) for comparison. The trial suits healthy adults with a wound but no other skin conditions affecting their arms. Participants should follow a normal wound care plan and attend scheduled follow-up visits. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that you stop taking any aminopyridine medications, including other compounded 4-AP, and organic cat-ion transporter 2 (OCT2) inhibitors like Cimetidine.

Is there any evidence suggesting that 4-aminopyridine is likely to be safe for humans?

Research has shown that 4-aminopyridine (4-AP) is generally safe, based on past studies. It is already used for conditions like multiple sclerosis. In those cases, some people experienced side effects such as dizziness, trouble sleeping, and nausea, but these were uncommon, and only a few discontinued use due to these effects.

In animal studies, 4-AP accelerated wound healing without causing serious problems. Another study described 4-AP as a promising treatment with a strong safety record, particularly for healing wounds and burns.

Overall, while some mild side effects have been noted in other uses of 4-AP, it has been generally well-tolerated. This suggests it could be a safe option for aiding faster wound healing.12345

Why do researchers think this study treatment might be promising?

4-Aminopyridine is unique because it offers a new way to aid skin wound healing by targeting nerve cell activity. Unlike current treatments that typically focus on cleaning wounds, preventing infection, or promoting tissue regeneration, 4-aminopyridine works by enhancing nerve transmission, potentially speeding up the healing process. Researchers are excited about this treatment as it taps into the body's nervous system to promote healing, which is a novel approach compared to standard wound care therapies.

What evidence suggests that 4-aminopyridine might be an effective treatment for wound healing?

Research has shown that 4-aminopyridine (4-AP) can accelerate wound healing. In animal studies, 4-AP helped skin wounds in mice heal faster by speeding up wound closure and aiding the skin's return to normal. It also reduced swelling and cell damage, both crucial for healing. Another study found that 4-AP promoted the growth of skin cells and hair follicles, which are key for wound recovery. In this trial, participants will receive either 4-AP or a placebo to evaluate its effectiveness in accelerating wound healing. These findings suggest that 4-AP could be a promising treatment for enhancing wound recovery.12567

Who Is on the Research Team?

JE

John Elfar, MD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

This trial is for adults with chronic non-healing wounds or acute wounds. Participants should be in good health overall, aside from their wound condition.

Inclusion Criteria

Ability to give written informed consent
I can assess and report on my wound healing and any changes in feeling or movement.
I am healthy and do not have skin conditions on my underarm or upper inner arm.
See 2 more

Exclusion Criteria

Pregnancy, breastfeeding, or incarcerated individuals
Patients with a concomitant traumatic brain injury
Suspected renal impairment based on the Choyke questionnaire
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 4-aminopyridine or placebo for wound healing

6 weeks
Bi-weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • 4-Aminopyridine
Trial Overview The study tests if 4-aminopyridine (4-AP), a new agent thought to be safe, can speed up the healing of wounds. Some participants will receive 4-AP while others will get a placebo for comparison.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Group A: 4-aminopyridineActive Control1 Intervention
Group II: Group B: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

John Elfar

Lead Sponsor

Trials
4
Recruited
500+

Citations

4-Aminopyridine Induces Nerve Growth Factor to Improve ...We now report that, in mice with full-thickness dorsal skin wounds, the systemic 4-AP treatment caused more rapid wound closure, restoration of normal epidermal ...
NCT06333171 | 4-aminopyridine for Skin Wound Healing4-AP administration over just 21 days led to a large augmentation of wound healing at time points as early as three days post injury. 4-AP treatment was ...
4-aminopyridine promotes accelerated skin wound healingWe now provide evidence that 4-AP treatment of mice with acute skin wounds promotes faster wound healing, extensive changes in wound ...
4-aminopyridine attenuates inflammation and apoptosis ...We recently found that 4-AP treatment enhanced wound healing and hair follicle regeneration by augmenting keratinocyte, fibroblast, and Schwann- ...
4-aminopyridine attenuates inflammation and apoptosis and ...Our data supports a novel therapeutic application of 4-AP in promoting cutaneous burn healing, which is clinically translatable. Results. 4-AP expedited burn ...
Functional improvement in individuals with chronic spinal cord ...The TEAEs most frequently associated with discontinuation were dizziness (8%), insomnia (4%) and nausea (3%). Only one serious adverse event ( ...
NCT06596434 | 4-Aminopyridine to Treat Skin BurnsMore research is needed to evaluate the role of 4-AP, a promising new agent with an excellent safety profile, on wound and burn healing. The investigational ...
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